Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.
Recalled June 1, 2022 · FDA recall D-0893-2022 · Direct Rx
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . · FDA Class II
Units
11 bottles
Sold at
FL
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Product
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →